Public Policy
Concerns raised that EU Health Technology Assessment Regulation could lead to delays in market approval.
The Oxehealth Vital Signs system is installed in a patient's hospital room, where it can spot-measure pulse, heart, respiratory and breathing rates with no physical contact.
According to FDA documents, the test is intended to help stop the spread of COVID-19 among Amazon employees.
Since January 2021, all 72 million statutorily insured German citizens have been legally entitled to a national electronic patient record (ePA).
The agency will allow some COVID-19 tests to be used at home for regular asymptomatic testing.
The system delivers its results to a companion app in about 20 minutes, according to the agency.
Media reports indicate that One Medical has allowed people connected with company executives and other ineligible individuals to skip the vaccination line.
The Analytic for Hemodynamic Instability tool can identify hemodynamic instability with 96% sensitivity and detects stable patients with 85% specificity.
Industry regulatory leaders outline the best approaches for digital health companies looking to make sense of FDA's long-in-the-tooth enforcement discretion guidelines.
Bradley Merrill Thompson, an FDA-watcher, lawyer and occasional MobiHealthNews guest contributor, joins the MobiHealthNews team for a closer look at what the FDA has been up to around digital health and AI.